NCT03760562

Brief Summary

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008, it was estimated that 0.8% of the United Kingdom adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years. The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111,804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
17.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

17.1 years

First QC Date

November 28, 2018

Last Update Submit

November 29, 2018

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Glucocorticoid-related hypertension

    Number of patients with incident hypertension

    18 years

Interventions

GlucocorticoidsDRUG

Oral Glucocorticoids.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients registered in Clinical Practice Research Datalink (CPRD) who were eligible for data linkage and had been diagnosed with at least one of six chronic inflammatory diseases (inflammatory bowel diseases, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, rheumatoid arthritis, and vasculitis) in the period between 1st Jan 1998 and 15th March 2017.

You may qualify if:

  • Patients aged 18 years old or over
  • Registered in a participating general practice 1 year or more during the study period
  • Minimum of 1 year prior to study entry meeting CPRD data quality
  • Diagnosed with at least one of the 6 chronic inflammatory diseases

You may not qualify if:

  • Patients aged under 18 years during the study period
  • Registered in general practices that did not consent to data linkage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mebrahtu TF, Morgan AW, West RM, Stewart PM, Pujades-Rodriguez M. Oral glucocorticoids and incidence of hypertension in people with chronic inflammatory diseases: a population-based cohort study. CMAJ. 2020 Mar 23;192(12):E295-E301. doi: 10.1503/cmaj.191012.

    PMID: 32392512DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2018

First Posted

November 30, 2018

Study Start

January 1, 1998

Primary Completion

January 30, 2015

Study Completion

September 30, 2015

Last Updated

November 30, 2018

Record last verified: 2018-11